The Effect of PXR Activation on Blood Pressure Regulation

Phase 4

Completed

• Conditions: Blood Pressure Regulation
• Interventions: Drug: Placebo; Drug: Rifampicin

• Registration Number: NCT01690104
• Lead Sponsor: University of Oulu

Brief Summary

We are investigating the effects of pregnane X receptor (PXR) activation on the regulation of blood pressure in healthy volunteers. Rifampicin (an antibiotic and also an efficient PXR activator) and placebo will be given for a week to volunteers and blood pressure is measured 24 hours using an ambulatory blood pressure monitor. Blood pressure regulating hormones will be measured in blood. Our hypothesis is that PXR is involved in the regulation of blood pressure.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Status Verified: 2012-09
• Study First Submitted: 2012-09-07
• Study First Submitted QC: 2012-09-17
• Study First Posted: 2012-09-21
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Last Update Submitted: 2014-12-29
• Last Update Posted: 2014-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Healthy volunteers
• BMI 19-30 kg/m2
• Age 18-40 years
• Systolic blood pressure 95 - 140 mmHg

Exclusion Criteria

• Any continuous medication
• Any significant medical condition as judged by the study physician
• Diastolic blood pressure over 90 mmHg
• Sensitivity to rifampicin
• Pregnancy and lactation
• Difficult venipuncture
• Abuse of alcohol or medications, or drug use.
• Participation in other trial with medications in previous 30 days

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo daily
Rifampicin	Rifampicin	Rifampicin 600 mg daily

Primary Outcome Measures

Name	Time	Method
Diastolic ambulatory blood pressure	On day 8 of each arm	Diastolic blood pressure measured with ambulatory blood pressure monitor
Systolic ambulatory blood pressure	On day 8 of each arm	Systolic blood pressure measured with ambulatory blood pressure monitor.

Secondary Outcome Measures

Name	Time	Method
Systolic and diastolic blood pressure	On day 9 of each arm
Pulse (ambulatory)	On day 8 of each arm
Plasma renin activity	On day 9 of each arm
Serum aldosterone	On day 9 of each arm

Trial Locations

Locations (1)

Oulu University Hospital; 🇫🇮 Oulu, Finland